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Recall Observatory FDA recall evidence

Device product

Medtronic CareLink Encore 29901 Programmer

Z-0407-2019

October 02, 2018

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 81300
Status
Ongoing
Classification
Class II
Quantity
4072 units
Official record key
device-enforcement:Z-0407-2019

Official wording

Reason: Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

Code information: All Serial Numbers

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.